This project will involve development leading to large batch production of sterile products, most of which will involve freeze-dried preparations. Provide support and backup capability to the existing contractor for large-scale parenteral manufacture. The contractor will be expected to perform preformulation studies on investigational substances including analytical development and solubility and stability studies. It is expected that the contractor will complete ten production projects a year of batch sizes from 5,000 to 10,000 vials. The products are to be prepared under current Good Manufacturing Practices (GMPs) and will have to meet analytical and safety standards for parenteral products.